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Study on Prednisone and Antihistamine for Treating Acute Urticaria in Adults at the Emergency Department

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of acute urticaria, a condition characterized by sudden outbreaks of red, itchy welts on the skin, often accompanied by swelling known as angioedema. The study is being conducted in emergency departments and involves adult patients who experience this condition. The treatment being tested includes the use of a medication called prednisone, which is a type of corticosteroid, in combination with an antihistamine. A placebo is also used in the study for comparison purposes.

The purpose of the study is to determine if using just an antihistamine is as effective as using both an antihistamine and a corticosteroid like prednisone in treating acute urticaria. Participants in the study will receive either the combination of medications or the antihistamine alone. The study will monitor the effectiveness of these treatments over a period of time, with a focus on the symptoms experienced by the patients.

Throughout the study, the progress of the participants will be tracked to assess the severity of their urticaria symptoms. This will help researchers understand the best approach to managing acute urticaria in emergency settings, potentially leading to improved treatment strategies for patients experiencing this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as being over 18 years old, having acute urticaria with angioedema, and providing consent.

    Participation requires social security affiliation.

  2. Step 2

    Initial treatment

    The treatment involves the administration of a single antihistamine or a combination of an antihistamine and a corticosteroid.

    The corticosteroid used is prednisone, provided as CORTANCYL 20 mg tablets, taken orally.

  3. Step 3

    Medication administration

    The medication is administered as a single dose.

    The aim is to assess the effectiveness of the treatment in managing acute urticaria symptoms.

  4. Step 4

    Monitoring and assessment

    The primary measure of success is the 7-Days Urticaria Activity Score (UAS 7) evaluated on day 7.

    This score helps determine the effectiveness of the treatment in reducing urticaria symptoms.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by September 21, 2025.

    Participants' progress and outcomes are documented for analysis.

Who can join the trial?

4 criteria

  • Must be an adult, meaning you need to be older than 18 years.
  • Have a condition called acute urticaria, which is a sudden outbreak of red, itchy welts on the skin, along with angioedema, which is swelling under the skin, but without swelling in the throat area (laryngeal edema).
  • Need to give your consent, which means you agree to participate in the study after understanding what it involves.
  • Must be affiliated with social security, meaning you have some form of social health insurance or coverage.

Who cannot join the trial?

4 criteria

  • Patients who are not adults cannot participate.
  • Patients who do not have acute urticaria (a sudden outbreak of red, itchy welts on the skin) cannot participate.
  • Patients who are not visiting the emergency department for their condition cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
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Investigated drugs

  • Antihistamine

    is a medication used to relieve symptoms of allergies, such as itching, swelling, and rashes. In this trial, it is being tested to see if it can effectively treat acute urticaria, which is a sudden outbreak of hives, without the need for additional medications.

  • Corticosteroid

    is a type of medication that reduces inflammation and suppresses the immune system. It is often used in combination with antihistamines to treat severe allergic reactions, including acute urticaria. In this trial, it is being used to compare its effectiveness when combined with an antihistamine against using an antihistamine alone.

What is already known about the treatment

  • Antihistamine

    This medication is typically administered orally and is used to treat symptoms of acute urticaria, such as itching and swelling, by blocking histamine receptors in the body. It is widely recognized in medical literature as an effective treatment for allergic reactions. The main therapeutic indication is for the relief of symptoms associated with acute urticaria. At the molecular level, antihistamines work by preventing histamine, a chemical released during allergic reactions, from binding to its receptors, thereby reducing allergic symptoms. They are classified pharmacologically as H1 receptor antagonists.

  • Corticosteroid

    This medication can be administered orally or via injection and is used to reduce inflammation and suppress the immune response in conditions like acute urticaria. It is well-documented in medical literature for its effectiveness in managing severe allergic reactions and inflammation. The primary therapeutic indication is to control severe allergic reactions and reduce inflammation. At the molecular level, corticosteroids work by inhibiting the production of substances that trigger inflammatory and immune responses. They are classified as anti-inflammatory agents.

Investigated diseases

Acute Urticaria – Acute urticaria is a skin condition characterized by the sudden appearance of red, itchy welts or hives on the skin. These welts can vary in size and may appear and disappear quickly, often within a few hours. The condition is usually triggered by an allergic reaction to certain foods, medications, or other substances. In some cases, the exact cause may not be identified. The hives can be accompanied by swelling, known as angioedema, particularly around the eyes, lips, and throat. While the condition is often uncomfortable, it typically resolves on its own within a few days to weeks.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515308-38-00Protocol codeP160913Estimated enrolment240 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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